FDA has approved Camptosar (irinotecan) for a new indication for
first-line therapy in combination with 5-fluorouracil and leucovorin (5-
FU/LV) to treat metastatic colorectal cancer. The following may be used
to respond to questions.
It is estimated that about 130,000 people in the United States will
be diagnosed with colorectal cancer this year. Primary treatment consists
of surgery with or without adjuvant chemotherapy or radiation. About
half the people treated this way will progress to metastatic disease
(cancer that has spread outside of the colon or rectum). In these
patients, 5-fluorouracil plus leucovorin (5FU/LV) in combination has been
standard treatment. Camptosar was shown in two controlled studies to
increase survival when it was added to 5-FU/LV in patients wit metastatic
Approval of the new indication was based on two randomized,
controlled, clinical trials in more than 800 patients comparing Camptosar
in combination with 5-FU/LV to 5FU/LV without Camptosar. In the studies,
the combination of Camptosar and 5FU/LV resulted in a significant delay
in the time at which tumors progressed and significant improvement in
survival compared with 5-FU/LV alone.
In one study, the median survival for patients on the regimen
including Camptosar was 17.4 months for patients treated with Camptosar
and 5-FU/LV administered by slow infusion compared to 14.1 months for
patients treated with slow infusional 5-FU/LV alone. In the other study
the median survival for patients treated with Camptosar plus a rapid
infusion (bolus) of 5-FU/LV was 14.8 months compared to 12.6 months for
patients treated with a different regimen of bolus 5-FU/LV alone.
Side effects of Camptosar include severe diarrhea (which can be
prolonged and require supportive medical treatment), nausea, vomiting and
neutropenia (drop in white blood cells).
On March 16, 2000, the FDA's Oncologic Drugs Advisory Committee
unanimously recommended approval of the Camptosar plus 5-FU/LV regimen
and agreed that this combination therapy is an important alternative for
In 1996, Camptosar was granted accelerated approval for treatment of
patients with metastatic carcinoma of the colon or rectum whose disease
had recurred or progressed following 5-FU based therapy.
Accelerated approval is a regulatory mechanism that allows early
approval of cancer drugs based on the effect on the tumor (shrinkage)
rather than a clearly beneficial effect on the patient (better survival)
on the condition that survival effects be studied. In l998, survival
studies for Camptosar in refractory disease showed an effect on survival
in patients whose cancer had recurred or progressed on 5FU.
Camptosar(administered by infusion) is manufactured
by Pharmacia Corp of Peapak, New Jersey.
For more information on Camptosar, visit the Pharmacia Web site